![LA MER THE REPARATIVE SKIN TINT BROAD SPECTRUM SPF 30 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) LOTION [MAX HUBER RESEARCH LAB INC]](https://medic.hrt.org//dailymed/images/0f427ae2-f806-4fe8-9bbe-6eb859cf0f21/5ark-01.jpg)
| NDC | 65966-017-01 |
| Set ID | 0f427ae2-f806-4fe8-9bbe-6eb859cf0f21 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | MAX HUBER RESEARCH LAB INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- –
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- –
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
-
Inactive Ingredients
WATER\AQUA\EAU • BUTYLENE GLYCOL • OCTYLDODECYL NEOPENTANOATE • CETYL ALCOHOL • LAURETH-4 • ASCORBYL GLUCOSIDE • NEOPENTYL GLYCOL DIHEPTANOATE • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • POLYETHYLENE • HELICHRYSUM ARENARIUM (EVERLASTING) EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • MAGNOLIA OFFICINALIS BARK EXTRACT • PEG-100 STEARATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • MORUS NIGRA (MULBERRY) ROOT EXTRACT • HYDROGENATED LECITHIN • CORALLINA OFFICINALIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • VITIS VINIFERA (GRAPE) FRUIT EXTRACT • SACCHAROMYCES LYSATE EXTRACT • MENTHA VIRIDIS (SPEARMINT) • PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL • LAMINARIA SACCHARINA EXTRACT • CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL • LAMINARIA DIGITATA EXTRACT • METHYLDIHYDROJASMONATE • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • ACETYL HEXAPEPTIDE-8 • SUCROSE • GLYCERIN • GLYCYRRHETINIC ACID • CAFFEINE • PROPYLENE GLYCOL DIETHYLHEXANOATE • LECITHIN • ISOHEXADECANE • POLYGLYCERYL-3 BEESWAX • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • DIMETHOXYTOLYL PROPYLRESORCINOL • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • ACETYL GLUCOSAMINE • PVP/HEXADECENE COPOLYMER • TOURMALINE • YEAST POLYSACCHARIDES • CAPRYLYL GLYCOL • ROSA DAMASCENA (ROSE) FLOWER OIL • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • ISOSTEARIC ACID • PROPYLENE GLYCOL DICAPRATE • STEARIC ACID • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • TROMETHAMINE • ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER • GALACTOARABINAN • NYLON-12 • ZEOLITE • SYNTHETIC FLUORPHLOGOPITE • TOCOPHERYL LINOLEATE/OLEATE • SODIUM HYALURONATE • BORON NITRIDE • XANTHAN GUM • POLYSORBATE 80 • SILICA • ALUMINUM HYDROXIDE • ALCOHOL DENAT. • TIN OXIDE • DISODIUM EDTA • BHT • LINALOOL • GERANIOL • CITRONELLOL • LIMONENE • PHENOXYETHANOL • [+/- TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499) • MICA] <ILN41371>
- Other information
- PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
LA MER THE REPARATIVE SKIN TINT BROAD SPECTRUM SPF 30
octinoxate, octisalate, and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0825 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.022 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.053 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CETYL ALCOHOL (UNII: 936JST6JCN) LAURETH-4 (UNII: 6HQ855798J) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SESAME OIL (UNII: QX10HYY4QV) ALFALFA SEED (UNII: 67PHZ58858) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) EUCALYPTUS OIL (UNII: 2R04ONI662) SODIUM GLUCONATE (UNII: R6Q3791S76) COPPER GLUCONATE (UNII: RV823G6G67) CALCIUM GLUCONATE (UNII: SQE6VB453K) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) NIACIN (UNII: 2679MF687A) SESAME SEED (UNII: 7Y1255HVXR) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CUCUMBER (UNII: YY7C30VXJT) MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974) PEG-100 STEARATE (UNII: YD01N1999R) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) MORUS NIGRA ROOT (UNII: 033456LFG1) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CORALLINA OFFICINALIS (UNII: 4004498D06) GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE) WINE GRAPE (UNII: 3GOV20705G) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) MENTHA SPICATA (UNII: O2H83I4PUN) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) LAMINARIA DIGITATA (UNII: 15E7C67EE8) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) ENOXOLONE (UNII: P540XA09DR) CAFFEINE (UNII: 3G6A5W338E) PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z) ISOHEXADECANE (UNII: 918X1OUF1E) WHEY (UNII: 8617Z5FMF6) LIME PEEL (UNII: 544EQK5Q0W) N-ACETYLGLUCOSAMINE (UNII: V956696549) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) ISOSTEARIC ACID (UNII: X33R8U0062) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) STEARIC ACID (UNII: 4ELV7Z65AP) BARLEY (UNII: 5PWM7YLI7R) TROMETHAMINE (UNII: 023C2WHX2V) GALACTOARABINAN (UNII: SL4SX1O487) NYLON-12 (UNII: 446U8J075B) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BORON NITRIDE (UNII: 2U4T60A6YD) XANTHAN GUM (UNII: TTV12P4NEE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALCOHOL (UNII: 3K9958V90M) STANNIC OXIDE (UNII: KM7N50LOS6) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LINALOOL, (+/-)- (UNII: D81QY6I88E) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65966-017-01 1 in 1 CARTON 02/10/2015 1 40 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/10/2015 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(65966-017) , REPACK(65966-017) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(65966-017) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(65966-017) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(65966-017) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(65966-017) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(65966-017) , REPACK(65966-017) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(65966-017) , REPACK(65966-017) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(65966-017) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(65966-017)
